Whole-Brain Radiotherapy (WBRT) Versus WBRT and Integrated Boost Using Helical Tomotherapy for Multiple Brain Metastases
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|ClinicalTrials.gov Identifier: NCT00876759|
Recruitment Status : Unknown
Verified April 2009 by University Hospital, Essen.
Recruitment status was: Recruiting
First Posted : April 7, 2009
Last Update Posted : April 7, 2009
Brain metastases occur in 20-40% of patients with primary extracerebral tumors. Despite important advances in therapy of malignant solid tumors and treatment of 1-3 brain metastases, multiple brain metastases continue to present a significant problem in attempting to prevent progression of disease and limit morbidity associated with therapy. The majority of patients who develop brain metastases have a short survival, effective palliation being transient. The median survival after diagnosis is as low as 3-6 months. However, there is some evidence that selected patients survive prolonged periods with vigorous therapeutic approach.
Specific therapeutic options are surgery, chemotherapy, conventional fractionated whole-brain radiotherapy (WBRT) and radiosurgery. Radiosurgery allows delivering of a single high dose fraction of radiation to targets of 3-3.5 cm maximum diameter. In patients with newly diagnosed brain metastases, a rapid decrease of symptoms, local tumor response rate of 73-90% and a median survival of 7-12 month have been reported.
WBRT alone is the treatment of choice for patients with multiple brain metastases, and for patients with single brain metastases not amenable to surgery or radiosurgery. Median survival after WBRT alone is 3-6 months.
WBRT and radiosurgery boost have been shown to improve survival in RPA class I patients and in patients with favorable histological status and squamous cell or non-small cell lung tumors. All randomized trials showed improved local control with the addition of radiosurgery to WBRT (Andrews, 2004).
WBRT in conjunction with radiosurgery improves local control and reduces the risk of new distant brain metastases, but most studies support that combined radiosurgery and WBRT does not improve the overall survival expect for patients without evidence of extracranial disease.
Helical Tomotherapy (HT) allows as a sole modality a new treatment option: Using HT, the advantage of applying a highly conformal boost dose to the metastases and WBRT can be combined in one treatment session. Therefore, it allows applying a high dose to multiple brain metastases in the sense of an integrated boost. The focus of this study is to investigate the efficacy and safety of WBRT with an integrated boost using this new treatment modality in comparison to the effects of conventional WBRT alone.
The principal objective of the trial is to assess the therapeutic efficacy of WBRT as compared to WBRT combined with integrated boost with HT delivered to patients with 2-10 brain metastases of solid tumors. The secondary objective is to evaluate the safety of WBRT as opposed to WBRT combined with integrated boost as delivered by HT in patients with 2-10 brain metastases.
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Radiation: whole brain radiotherapy Radiation: whole brain radiotherapy with simultaneous boost||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Whole-Brain Radiotherapy (WBRT) vs. WBRT and Integrated Boost Using Helical Tomotherapy for Patients With Multiple Brain Metastases - a Multicentre Randomized Phase II Trial|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||July 2013|
Active Comparator: WBRT
standard WBRT to a total dose of 30 Gy in 10 fractions
Radiation: whole brain radiotherapy
WBRT in 10 fractions to a total dose of 30Gy
Experimental: WBRT with simulatneous boost
The experimental group will be treated with helical tomotherapy giving 3 Gy per fraction to the whole brain up to a total dose of 30 Gy in 10 fractions and raising the prescribed dose to the brain metastases to 5 Gy per fraction. The dose fall off to the normal brain should be as steep as possible around each brain metastasis. The optic chiasm and the optic nerves should not receive more than 3.5 Gy per fraction.
Radiation: whole brain radiotherapy with simultaneous boost
Total dose: 10 fractions: whole brain total dose: 30Gy, metastases: total dose 50Gy
- time to morphologic progression in the brain as evidenced on MRI (RECIST criteria) [ Time Frame: 2 years ]
- local tumor control as evidenced by MRI [ Time Frame: 2 years ]
- time to neurocognitive progression [ Time Frame: 2 years ]
- time to deterioration of functional independence [ Time Frame: 2 years ]
- quality of life [ Time Frame: 2 years ]
- overall survival, cause of death distribution [ Time Frame: 2 years ]
- toxicity as evidenced by CTC-criteria [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876759
|Contact: Andrea Wittig, MD||+49201723 ext firstname.lastname@example.org|
|Contact: Martin Stuschke, MD pHD||+49201723 ext email@example.com|
|University Duisburg-Essen, Medical Faculty, department of Radiation Oncology||Recruiting|
|Essen, NRW, Germany, 45122|
|Contact: Andrea Wittig, MD +49201723 ext 2050 firstname.lastname@example.org|
|Contact: Martin stuschke, MDpHD +49201723 ext 2321 email@example.com|
|Principal Investigator: Martin Stuschke, MD pHD|
|Klinik für Strahlentherapie Charite Campus Mitte||Not yet recruiting|
|Berlin, Germany, 10117|
|Contact: Volker Budach, MD pHD +49-30-450527 ext 021 firstname.lastname@example.org|
|Contact: Simone Marnitz, MD pHD 49-30-450527 ext 162 Simone.Marnitz@charite.de|
|Principal Investigator: Volker Budach, MD pHD|
|Universitätsklinikum Hamburg Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Strahlentherapie,||Not yet recruiting|
|Hamburg, Germany, 20246|
|Contact: Rudolf Schwarz, MD pHD 040 42803 ext 5425 email@example.com|
|Principal Investigator: Rudolf Schwarz, MDpHD|
|Jürgen Debus||Not yet recruiting|
|Heidelberg, Germany, 69120|
|Contact: Jürgen Debus, MD pHD +49-6221 ext 56 8202 firstname.lastname@example.org|
|Contact: Klaus Herfarth, MDpHD +49-6221 ext 56 8202 email@example.com|
|Principal Investigator: Klaus Herfarth, MD pHD|
|Klinik und Poliklinik für Strahlentherapie und Radiologische Onkologie, Klinikum rechts der Isar, Technische Universität München||Not yet recruiting|
|München, Germany, 81675|
|Contact: Michael Molls, MD pHD + 49 89 4140 ext 4501 Molls@lrz.tu-muenchen.de|
|Contact: Hans Geinitz, MD pHD 089/4140 ext 4525 firstname.lastname@example.org|
|Principal Investigator: Hans Geinitz, Md pHD|
|Principal Investigator:||Martin Stuschke, MD pHD||University Duisburg-Essen, Medical Faculty, Department of Radiation Oncology|